Drugs / ARCT-032
Trials 2
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT05712538 | Feb 2023 → Jul 2024 | cystic fibrosis | Arcturus Therapeutics, Inc. | Completed | No outcome recorded |
| Phase 21 trial | ||||||
| Phase 2 | NCT06747858 | Dec 2024 → Jun 2027 expected | CFTR-related disorder, cystic fibrosis | Arcturus Therapeutics, Inc. | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 10
| Date | Issuer | Release |
|---|---|---|
| 2026-03-03 | Arcturus Therapeutics, Inc. | Results Arcturus Therapeutics Announces Fourth Quarter and Fiscal Year 2025 Financial Results and Pipeline Progress arcturusrx.com ↗
Arcturus has completed once-daily dosing of 15 mg of ARCT-032 over 28 days in the third dosing cohort, among four Class I adults with CF, and observed no safety or tolerability issues in this higher dosing cohort. |
| 2025-10-22 | Arcturus Therapeutics, Inc. | Results Arcturus Therapeutics Provides Interim Phase 2 Data for Cystic Fibrosis (CF) Program arcturusrx.com ↗
After only 28 days of treatment with ARCT-032 (10 mg), 4 out of 6 Class I CF participants exhibited encouraging reduction of mucus plug number and mucus volume |
| 2024-09-03 | Arcturus Therapeutics, Inc. | Regulatory Arcturus Therapeutics Receives Clearance of an Investigational New Drug Application to U.S. Food and Drug Administration for ARCT-032, an Investigational Inhaled mRNA Therapeutic to Treat Cystic Fibrosis arcturusrx.com ↗ |
| 2024-06-07 | Arcturus Therapeutics, Inc. | Results Arcturus Therapeutics Presents New Clinical Data at 47th Annual European Cystic Fibrosis Conference arcturusrx.com ↗
The Phase 1b trial showed improvements in FEV1 (Forced Expiratory Volume in 1 second) in the four adults with CF after two inhaled administrations. |
| 2024-05-28 | Arcturus Therapeutics, Inc. | Results Arcturus Therapeutics Announces Positive Development for Cystic Fibrosis Program arcturusrx.com ↗
The absolute change in percent predicted FEV1 (Forced Expiratory Volume in 1 second) in the first four CF participants was observed to be an average of 4.0% at day 8, |
| 2024-02-22 | Arcturus Therapeutics, Inc. | Regulatory Arcturus Therapeutics Receives Orphan Medicinal Product Designation from the European Commission (EC), for ARCT-032, for the Treatment of Cystic Fibrosis arcturusrx.com ↗ |
| 2023-11-27 | Arcturus Therapeutics, Inc. | Regulatory Arcturus Therapeutics Receives Orphan Drug Designation from the U.S. FDA for ARCT-032, for the Treatment of Cystic Fibrosis arcturusrx.com ↗ |
| 2023-11-14 | Arcturus Therapeutics, Inc. | Regulatory Arcturus Therapeutics Announces Third Quarter 2023 Financial Update and Pipeline Progress arcturusrx.com ↗
ARCT-032 received Rare Pediatric Disease Designation for cystic fibrosis from the FDA |
| 2023-01-31 | Arcturus Therapeutics, Inc. | Regulatory Arcturus Therapeutics Announces Clinical Trial Application for ARCT-032 Received Approval to Proceed into First-in-Human Studies to Treat Cystic Fibrosis arcturusrx.com ↗
today announced that the Clinical Trial Application (CTA) for ARCT-032, an inhaled investigational mRNA medicine to treat cystic fibrosis (CF), received approval to proceed into a Phase 1 First-in-Human study in New Zealand . |
| 2022-11-09 | Arcturus Therapeutics, Inc. | Results Arcturus Therapeutics Announces Third Quarter 2022 Financial Update and Pipeline Progress arcturusrx.com ↗ |
All press releases naming this drug 13 releases
Evidence & citations 4 cited values
Every value below carries the sentence it was read from. 2 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | ARCT-032 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05712538 ↗ |
| Modality | Messenger RNA (mRNA) | “ARCT-032 is messenger RNA (mRNA) coding for cystic fibrosis transmembrane conductance regulator (CFTR) protein” NCT05712538 ↗ |
| Route | Inhaled | “inhale two doses of nebulized ARCT-032” NCT05712538 ↗ |
| Target | CFTR | “CFTR mRNA formulated in lipid nanoparticles” NCT06747858 ↗ |